Feasibility and Safety of a Portable Exoskeleton to Improve Mobility in Parkinson's Disease

NCT06028529 | Recruiting FDA Device

• 1 other identifier: N4387-P
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Physical therapy approaches for balance and walking deficits in Parkinson's disease (PD) have limited effectiveness, with mostly short-lasting benefits. An exoskeleton is a device that straps to the legs and provides a passive force to assist people to better ambulate. The goal of this study is to establish the feasibility and safety of a lightweight exoskeleton on mobility and fall reduction in people with PD. As most PD patients eventually require assistive mobility devices, the exoskeleton represents a new option for increased, mobility, quality of life, and independence. Qualified subjects will come to the clinic twice weekly for eight weeks (16 total visits) and wear the exoskeleton device while walking under the supervision of a trained kinesiotherapist. Study staff will also interview participants and assess their PD symptoms, quality of life, and overall mobility. This study hopes to establish exoskeletons as modern, standard of care devices, which allow people with PD to maintain more independent and productive lives.

Conditions

Parkinson's Disease

Keywords

exoskeleton

Outcome Measures

Primary Outcomes (5)

• Incidence of Falls While Wearing the Exoskeleton (Safety and Tolerability) Change

  Patients will be continuously supervised by a trained physical therapist and the expectation is that there will be no falls while wearing the device. All primary safety and tolerability measures will be separately assessed with consideration of H\&Y staging (2-4; max. 5) and cognition (based on MOCA scores 0 = nl, max. 30). -Minimal attrition rate based on subjects being unable to complete the protocol. This could for example establish that the Keeogo device is not tolerated by more advanced (H\&Y Stage 5) patients, but is acceptable for others.

  Through last training visit (weeks 1-8, 16 sessions)

• Incidence of Attrition (Tolerability) Change

  The expectation is that there will be minimal attrition rate based on subjects being unable to complete the protocol. In the case of attrition, patients will be interviewed for contributory sources.

  Through last training visit (weeks 1-8, 16 sessions)

• Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) Change

  Patients will be questioned at the beginning of each session about potential AEs and any AEs observed during sessions by the therapists will be recorded at each training session. The expectation is that there will be no uncorrected and unacceptable AEs as captured by regular structured interviews.

  through last training visit (weeks 1-8, 16 sessions)

• Six-minute Walk Test (Suitability as a Future Primary Efficacy Measure) Change

  The suitability of the 6MWT as a future primary clinical outcome measure (and our secondary measures) will be determined from the therapists' impression of ease and reliability of usage and from anticipated trends in scoring improvement. The outcomes here from the 6MWT and secondary measures will be further used towards powering for a future clinical efficacy study, while accounting for preliminary defined influences of severity of PD (H\&Y Staging) and cognition (MOCA scoring). Additionally, 6- and 12-weeks post-training assessments will be used to preliminarily assess the durability of training effects.

  through last training visit (weeks 1-8, 16 sessions) and 6- and 12-wks post-training

• Patient Satisfaction

  All subjects will be interviewed for patient satisfaction with wearing and training with the exoskeleton.

  immediate post-training

Secondary Outcomes (2)

• Motor examination (Part III) of the modified Unified Parkinson's Disease Rating Scale (Suitability as a Future Secondary Efficacy Measure)

  immediate post-training, 6- and 12-wks post-training

• Mini Best Test (Suitability as a Future Secondary Efficacy Measure)

  immediate post-training, 6- and 12-wks post-training

Study Arms (1)

Feasibility and Safety

OTHER

This is a feasibility study to assess the safety and potential utility of a lightweight ground exoskeleton (Keeogo, B-Temia, Inc.) to enhance mobility in people with Parkinson's disease (PD).

Device: Exoskeleton

Interventions

Exoskeleton DEVICE

lightweight ground exoskeleton

Also known as: Keeogo

Feasibility and Safety

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• PD confirmed by a PADRECC movement disorder specialist using UK Brain Bank Criteria
• Modified H\&Y stage II-V
• Veteran
• Able to attend visits at the Richmond VA Medical Center

You may not qualify if:

• neurological, musculoskeletal, or other disorders unrelated to PD contributing to impairment of stance, gait, balance or coordination
• severe CHF, COPD, or those requiring nasal canula O2
• history of implantable cardiac device or ablative surgery
• moderately-severe to severe cognitive impairment / dementia (Montreal Cognitive Assessment \< 17/30)
• symptomatic orthostatic hypotension with exertion
• feeding tube or associated port placement (PEG/J-PEG)
• body height less than 5'1" or greater than 6'3"
• body weight greater than 250 pounds
• amputation of any portion of the lower limbs
• osteoporosis as defined by DEXA Scan T score \< -2.5
• failure to meet B-Temia-established hip and knee flexion and extension manual muscle test (MMT) prerequisite screening parameters, which assure that individuals can adequately engage and walk against the resistive forces of the Keeogo
• inability to complete 20 minutes of walking with the exoskeleton (over a maximum period of one hour) at the initial screening/testing session

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Richmond VA Medical Center, Richmond, VA

Richmond, Virginia, 23249-0001, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

Exoskeleton Device

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Jessica B Lehosit

  Richmond VA Medical Center, Richmond, VA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel G Sinclair, MPHA

CONTACT

(804) 675-5931; rachel.sinclair@va.gov

Jessica B Lehosit

CONTACT

(804) 675-5000; jessica.lehosit@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Safety, tolerability, feasibility, methodological assessment, and sample characteristics with consideration of multiple staging and high patient variability towards the design of a future clinical efficacy study.

Study Record Dates

• First Submitted: May 30, 2023
• First Posted: September 8, 2023
• Study Start: September 1, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)